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Health / Pharmacovigilance / Prostate cancer / Food and Drug Administration / Adverse event / Center for Biologics Evaluation and Research / Adverse effect / Pharmacology / Medicine / Pharmaceutical sciences


BLA STN[removed]Sipuleucel-T/Provenge® OBE/DE Review for Pharmacovigilance Planning - Provenge, December 8, 2006
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IndustryTerm

registry protocols / treatment for localized prostate cancer / healthcare services / autologous active cellular immunotherapy product / /

MedicalCondition

tumor / strokes / Cancer / chronic myelomonocytic leukemia / disease / secondary hematologic malignancies / Stroke / hematologic malignancies / invasive prostate cancer / localized prostate cancer / independent prostate cancer / secondary hematologic malignancy / refractory prostate cancer / prostate cancer / Sepsis / /

MedicalTreatment

leukopheresis / prostatectomy / immunotherapy / /

Organization

FDA / Medicare / /

Person

Robert Wise / Connell M.D. Ph / Lori Tull / M. Miles Braun / /

Position

Medical Officer / Director Background OBE/DE MPH Division / Regulatory Project Manager / MPH Branch Chief / Manager OCTGT/CBER Date / /

PublishedMedium

the OCTGT review / /

Technology

registry protocols / /

URL

www.cdc.gov/nchs/ndi.htm / www.fda.gov/cder/guidance/6358fnl.pdf / http /

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